Randomized clinical control study of locoregional therapy combined with arsenic trioxide for the treatment of hepatocellular carcinoma

Abstract

Background: The objective of this study was to determine the efficacy and safety of locoregional therapy (LRT) combined with arsenic trioxide (As2 O3 ) treatment in primary hepatocellular carcinoma (HCC) patients.

Methods: One hundred twenty-five primary HCC patients were recruited for a randomized controlled study. Patients were randomly divided into group A (n = 61) and group B (n = 64). All patients received transarterial chemoembolization. Group A patients were given As2 O3 at 10 mg/d for 4 courses (21 days per course) with a 2-week interval between courses. Survival times, therapeutic responses, extrahepatic metastases, and adverse events were recorded.

Results: A better therapeutic response was found in group A patients, as shown by higher objective response rate (ORR) and clinical benefit rate (CBR) values in group A versus group B (ORR, 81.96% [95% confidence interval (CI), 72.32%-91.62%] vs 59.37% [95% CI, 47.34%-71.41%], χ(2) = 7.650, P < .05; CBR, 95.08% [95% CI, 89.66%-100.00%] vs 81.25% [95% CI, 71.69%-90.81%], χ(2) = 5.659, P < .05). There were fewer patients with extrahepatic metastases in group A versus group B (group A, 6 cases or 9.84% [95% CI, 2.36%-17.31%]; group B, 12 cases or 18.75% [95% CI, 9.19%-28.31%]). The survival rate for group A patients was significantly higher than that for group B patients (P < .05). No significant differences were found between the 2 groups in terms of hematology or digestive system, liver, or kidney dysfunction except for facial and limb edema.

Conclusions: LRT combined with As2 O3 treatment prevents extrahepatic metastasis and prolongs the survival time for primary HCC patients.

Keywords: arsenic trioxide; extrahepatic metastasis; locoregional therapy; survival time.

© 2015 American Cancer Society.